国产大功率钬激光在剜除治疗前列腺增生中的研发与应用

Application of domestic high-power holmium laser in the enucleation of benign prostatic hyperplasia

目的:回顾性分析我科参与研发的国产80 W钬激光应用于剜除治疗良性前列腺增生(BPH)的临床数据,评价其安全性及疗效。方法:回顾性收集2012年1月~2014年12月行进口钬激光剜除治疗BPH 742例,2016年1月~2018年12月底行经国产钬激光剜除治疗BPH 857例,共1599例BPH患者纳入本次研究,收集两组患者手术前一般指标、术后6个月国际前列腺症状评分(IPSS)、生活质量评分(QOL),并统计所有患者术前术后血红蛋白下降值、剜除时间、剜除前列腺质量、术中术后膀胱冲洗时间、术后留置导尿时间等指标。结果:所有患者手术均为顺利完成,并据临床应用需求创新研发了100 W国产钬激光。两组患者IPSS评分、QOL评分等指标较术前均显著改善,比较差异无统计学意义(P>0.05);进口钬激光组手术时间略少于国产钬激光组,但差异无统计学意义[(38.25±11.54) min vs.(39.51±10.08) min,P=0.54];术后膀胱冲洗液用量国产钬激光组少于进口钬激光组,差异有统计学意义[(7.15±9.08) L vs.(10.01±8.62) L,P<0.05];IPSS评分、QOL评分等随访指标比较差异无统计学意义(P>0.05)。进口激光组包膜穿孔15例,国产激光包膜穿孔7例,两组比较差异有统计学意义(P<0.05)。结论:国产大功率钬激光应用于剜除治疗BPH疗效与进口钬激光相当,出现包膜穿孔率更低,术后冲洗液用量更少。

Objective: To evaluate the safety and efficacy of domestic high power holmium laser in enucleation of benign prostatic hyperplasia(BPH). Method: From January 2012 to December 2014, 742 patients with BPH underwent imported holmium laser enucleation, and from January 2016 to the end of December 2018, domestic holmium laser enucleation was performed for 857 BPH cases. A total of 1599 BPH patients were included in this study. The preoperative general indicators, IPSS and QOL score of the two groups were collected, and the preoperative and postoperative hemoglobin changes, operation time, prostate gland mass, bladder irrigation time, postoperative indwelling catheterization time and hospitalization time were collected. Result: All operations were successfully completed. IPSS and QOL of the two groups were significantly improved, but there was no significant difference between the two groups(P>0.05). The operation time of imported holmium laser group was slightly shorter than that of domestic holmium laser group [(38.25±11.54) min vs.(39.51±10.08) min, P=0.54], but the difference is not statistically significant. The amount of bladder irrigation fluid in domestic holmium laser group was less than that in imported holmium laser group [(7.15±9.08) L vs.(10.01±8.62) L, P<0.05]. There was no significant difference between the IPSS and QOL score at 6 months postoperative follow-up(P>0.05), There were 15 cases of capsule perforation in imported laser group and 7 cases in domestic laser group, The difference was statistically significant(P<0.05). Conclusion: The efficacy of domestic high-power holmium laser in enucleation of benign prostatic hyperplasia is similar to that of imported holmium laser. In addition, the domestic laser has lower perforation rate of capsule and less postoperative flushing fluid.